Hospira Recalls Propofol Injectable Vials Due to Particulate Matter
Hospira Inc. is recalling 56,420 vials of Propofol Injectable Emulsion because a visible particulate was found during inspection.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves particulate matter in an injectable drug. While Class II recalls are generally moderate, the specific finding of a single visible particulate in a sample bottle during inspection, without reported injuries or deaths, aligns with the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Hospira Inc. is recalling 56,420 vials of Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial. The recall is due to the presence of particulate matter, specifically a single visible particulate that was observed and confirmed in a sample bottle during retain inspection.
The affected product is distributed nationwide. The specific lot codes involved are 07-893-DJ (exp. 7/2013), 10-123-DJ, and 10-125-DJ (exp. 10/2013). The product is a prescription-only medication used for general anesthesia.
Healthcare providers and patients should check their inventory for these specific lot codes and expiration dates. If the product is found, it should be quarantined and not administered. Hospira Inc. is the recalling firm.
The recalled product
- Product
- PROPOFOL (PROPOFOL)
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Anesthetic
- Hazard
- Affected units
- 56,420
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 07-893-DJ
- exp. 7/2013
- 10-123-DJ
- 10-125-DJ
- exp. 10/2013
Distribution
Distributed nationwide across the United States.
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Similar recalls
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